velpatasvir and sofosbuvir
Drug Details
- Generic Name
- velpatasvir and sofosbuvir
- Brand Names
- N/A
- Application Number
- Sponsor
- Patheon Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- N/A
- Active Ingredients
- SOFOSBUVIR, VELPATASVIR
Indications and Usage
1 INDICATIONS AND USAGE EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2 , 2.3 , 2.4) and Clinical Studies (14) ] : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin. EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection ( 1 ): without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.